Anti-aging and Anti-oxidant Efficacy Evaluation of the MelaGene
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- The change of blood lipid (Triglyceride, total cholestrol, HDL-C, LDL-C)
研究概览
简要总结
The primary purpose of the present study is to evaluate the effects of MelaGene on anti-aging and anti-oxidant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •30 to 65-year-old;
- •Must read and sign the informed consent form before the experiment;
- •People who are willing to cooperate with contraception during the trial period;
- •Do not change lifestyle and eating habits arbitrarily during the trial period;
- •Do not take supplementary foods and health supplements with the same efficacy two weeks before and during the test;
- •If any adverse reaction occurs during the experiment, subjects should be notified the researcher immediately.
排除标准
- •Subject who is not willing to participate in this study;
- •Vegetarians;
- •People with a history of organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug abuse, and other major organic diseases (according to medical history);
- •Participate in other clinical trials related to antioxidants and anti-aging four weeks before and during the test;
- •People with a history of dyspepsia would affect the absorption of the test product;
- •Allergic to the components of the test product;
- •Pregnant or breast-feeding women;
- •Take anti-oxidant supplements;
- •Undergoing hormone replacement therapy.
结局指标
主要结局
The change of blood lipid (Triglyceride, total cholestrol, HDL-C, LDL-C)
时间窗: Days 1, 28, and 56
Venous blood is sampled to measure concentrations of blood lipid (Triglyceride, total cholestrol, HDL-C, LDL-C)
The change of ALT and AST
时间窗: Days 1, 28, and 56
Venous blood is sampled to measure concentrations of ALT and AST
The change of MDA
时间窗: Days 1, 28, and 56
Venous blood is sampled to measure concentrations of MDA
The change of blood antioxidants(f-Thiols, t-GSH, GST-RBC, SOD, Total Anit-oxidative Capicity)
时间窗: Days 1, 28, and 56
Venous blood is sampled to measure concentrations of blood antioxidants(f-Thiols, t-GSH, GST-RBC, SOD, Total Anit-oxidative Capicity)
The change of anti-aging gene expression
时间窗: Days 1, 28, and 56
Venous blood is sampled to measure expression of anti-aging gene
The change of cardiovascular endurance
时间窗: Days 1, 28, and 56
Step test is designed to assess cardiovascular endurance
次要结局
- The change of fatigue condition(Days 1, 28, and 56)
- The change of continuous attention test(Days 1, 28, and 56)